AMS INFLATABLE PENILE PROSTHESIS UNK-P-IPP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for AMS INFLATABLE PENILE PROSTHESIS UNK-P-IPP manufactured by Boston Scientific Corporation.

Event Text Entries

[185938239]
It was reported that the patient underwent an inflatable penile prosthesis (ipp) procedure due to the device was not working. It would not inflate or delate. All the components were removed and replaced with a new ipp system. No information about the patient's outcome was provided. Additional information received. According to the physician the implant was 10 years old. Patient Sequence No: 1, Text Type: D, B5